CSV Engineer

About Krystal Bio:

At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, and delivery of transformative medicines for people with serious and life-threatening genetic diseases. Founded in 2016, the Company is the leader in redosable gene therapy with prominent clinical and pre-clinical stage programs for dystrophic epidermolysis bullosa, TGM1-deficient ARCI, Netherton Syndrome, Cystic Fibrosis, alpha-1 antitrypsin deficiency, and is advancing research to apply our technology to these and other diseases. The Company’s innovation is fueled by visionary leadership within an entrepreneurial organizational structure with a robust pipeline of investigational medicine.

Our US headquarters is in Pittsburgh, PA with other offices located in Boston, MA and in Zug, Switzerland. For more information about the Company’s platform, commitment to patients and pipeline, please visit http://www.krystalbio.com and engage with us on Twitter and LinkedIn.

We have an exciting journey ahead and a tremendous opportunity for growth, and now is the time to make a meaningful impact on the lives of our patients!

Job Description Summary:

Krystal Biotech, is seeking a CSV Engineer to support our Pittsburgh laboratory/manufacturing facility. This is a full-time onsite position that will be responsible for supporting CSV activities of systems, equipment and programs requiring system and/or software qualification and testing.

Primary Responsibilities:

• Validation of new GxP computer systems/equipment used in QC & Manufacturing
• Developing and finalizing of validation documentation (URS, risk assessments, etc.)
• Supporting laboratory, facility and manufacturing systems as well as equipment post validation
• Ensuring adherence of computer systems to FDA 21CFR Part11 and/or Annex 11 compliance

Specifications:

• Must have a masters’ degree (or foreign equivalent degree) in Mechanical Engineering, Electrical Engineering, or a related field plus five (5) years of experience in a related position
• Experience must include five (5) years:
  • Authoring and executing validation protocols
  • Performing validation of laboratory, facility and/or manufacturing equipment
  • Working in FDA/cGMP environment
  • Background in pharma/biotech and or life sciences industry
  • Demonstrated technical writing background (SOP, WI, investigation/deviation reports, etc.)
  • IQ/OQ/PQ activities
  • Handling multiple projects independently with minimal supervision
  • Experience can be concurrent

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.

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